For IV or IM Use Only

Rx Only

Droperidol Injection, USP, is a sterile, non-pyrogenic, aqueous solution for intravenous or intramuscular use only.

Each mL contains:

Droperidol…………………………………….2.5 mg

Water for Injection………………………........q.s.

pH adjusted between 3.0 and 3.8 with lactic acid and, if necessary, with sodium hydroxide.

Droperidol is a neuroleptic (tranquilizer) agent. Chemically it is 1-(1-[3-(p-fluorobenzoyl)propyl]-1,2,3,6-tetrahydro-4-pyridyl)-2-benzimidazolinone and the structural formula is:

Droperidol produces marked tranquilization and sedation. It allays apprehension and provides a state of mental detachment and indifference while maintaining a state of reflex alertness.

Droperidol produces an antiemetic effect as evidenced by the antagonism of apomorphine in dogs. It lowers the incidence of nausea and vomiting during surgical procedures and provides antiemetic protection in the postoperative period.

Droperidol potentiates other CNS depressants. It produces mild alpha-adrenergic blockade, peripheral vascular dilatation and reduction of the pressor effect of epinephrine. It can produce hypotension and decreased peripheral vascular resistance and may decrease pulmonary arterial pressure (particularly if it is abnormally high). It may reduce the incidence of epinephrine-induced arrhythmias but it does not prevent other cardiac arrhythmias.

The onset of action of single intramuscular and intravenous doses is from three to ten minutes following administration, although the peak effect may not be apparent for up to thirty minutes. The duration of the tranquilizing and sedative effects generally is two to four hours, although alteration of alertness may persist for as long as twelve hours.

Droperidol Injection is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.

Droperidol is contraindicated in patients with known or suspected QT prolongation (i.e., QTc interval greater than 440 msec for males or 450 msec for females). This would include patients with congenital long QT syndrome.

Droperidol is contraindicated in patients with known hypersensitivity to the drug.

Droperidol is not recommended for any use other than for the treatment of perioperative nausea and vomiting in patients for whom other treatments are ineffective or inappropriate (see WARNINGS).

Droperidol should be administered with extreme caution in the presence of risk factors for development of prolonged QT syndrome, such as: 1) clinically significant bradycardia (less than 50 bpm), 2) any clinically significant cardiac disease, 3) treatment with Class I and Class III antiarrhythmics, 4) treatment with monoamine oxidase inhibitors (MAOI's), 5) concomitant treatment with other drug products known to prolong the QT interval (see PRECAUTIONS, Drug Interactions), and 6) electrolyte imbalance, in particular hypokalemia and hypomagnesemia, or concomitant treatment with drugs (e.g., diuretics) that may cause electrolyte imbalance.

QT interval prolongation, torsade de pointes, cardiac arrest, and ventricular tachycardia have been reported in patients treated with droperidol. Some of these cases were associated with death. Some cases occurred in patients with no known risk factors, and some were associated with droperidol doses at or below recommended doses.

Physicians should be alert to palpitations, syncope, or other symptoms suggestive of episodes of irregular cardiac rhythm in patients taking droperidol and promptly evaluate such cases (see WARNINGS, Effects on Cardiac Conduction).

The most common somatic adverse reactions reported to occur with droperidol are mild to moderate hypotension and tachycardia, but these effects usually subside without treatment. If hypotension occurs and is severe or persists, the possibility of hypovolemia should be considered and managed with appropriate parenteral fluid therapy.

The most common behavioral adverse effects of droperidol include dysphoria, postoperative drowsiness, restlessness, hyperactivity and anxiety, which can either be the result of an inadequate dosage (lack of adequate treatment effect) or of an adverse drug reaction (part of the symptom complex of akathisia).

Care should be taken to search for extrapyramidal signs and symptoms (dystonia, akathisia, oculogyric crisis) to differentiate these different clinical conditions.  When extrapyramidal symptoms are the cause, they can usually be controlled with anticholinergic agents.

Postoperative hallucinatory episodes (sometimes associated with transient periods of mental depression) have also been reported.

Other less common reported adverse reactions include anaphylaxis, dizziness, chills and/or shivering, laryngospasm and bronchospasm.

Elevated blood pressure, with or without pre-existing hypertension, has been reported following administration of droperidol combined with fentanyl citrate or other parenteral analgesics.  This might be due to unexplained alterations in sympathetic activity following large doses; however, it is also frequently attributed to anesthetic or surgical stimulation during light anesthesia.

Dosage should be individualized.  Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved.

Vital signs and ECG should be monitored routinely.

Adult Dosage: The maximum recommended initial dose of droperidol is 2.5 mg IM  or slow IV. Additional 1.25 mg doses of droperidol may be administered to achieve the desired effect. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.

Children’s Dosage: For children two to 12 years of age, the maximum recommended initial dose is 0.1 mg/kg, taking into account the patient's age and other clinical factors. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.

See WARNINGS and PRECAUTIONS for use of droperidol with other CNS depressants, and in patients with altered response.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.  If such abnormalities are observed, the drug should not be administered.

Droperidol Injection USP, (2.5 mg/mL) is available as:

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE.

1. Saarnivaara L, Klemola UM, Lindgren L, et al. QT interval of the ECG, heart rate and arterial pressure using propofol, methohexital or midazolam for induction of anaesthesia. Acta Anaesthesiol Scand 1990: 34: 276-81.
2. Schmeling WT, Warltier DC, McDonald DJ, et al. Prolongation of the QT interval by enflurane, isoflurane and halothane in humans. Anesth Analg 1991:72:137-44.
3. Spath G. Torsade des pointe oder die andere Ursache des plotz-lichen Herztodes. Wien: Ueberreuter. 1998.
4. Riley DC, Schmeling WT, al-Wathiqui MH, et al. Prolongation of the QT interval by volatile anesthetics in chronically instrumented dogs. Anesth Analg 1988: 67:741-9.
5. McConachie I, Keaveny JP, Healy TE, et al. Effects of anaesthesia on the QT interval. Br J Anaesth 1989:63:558-60.
6. Lawrence KR, Nasraway SA. Conduction disturbances associated with administration of butyrophenone antipsychotics in the critically ill: a review of the literature. Pharmacother 1997: 17(3):531-7.
7. Lischke V, Behne M, Doelken P, et al. Droperidol causes a dose-dependent prolongation of the QT interval. Anesth Analg 1994:79:983-6.

AMERICAN
REGENT, INC.
SHIRLEY,  NY 11967

IN9702
Rev. 1/09

NDC 0517-9702-01

DROPERIDOL
INJECTION, USP

5 mg/2 mL
(2.5 mg/mL)

2 mL SINGLE DOSE VIAL

FOR IV OR IM USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

DROPERIDOL
INJECTION, USP

5 mg/2 mL (2.5 mg/mL)

NDC 0517-9702-25
25 X 2 mL
SINGLE DOSE VIALS

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Rx Only

Each mL contains: Droperidol 2.5 mg, Water for Injection q.s. pH adjusted with Lactic Acid and, if necessary, with Sodium Hydroxide. CONTAINS NO PRESERVATIVES. DISCARD UNUSED PORTION. PROTECT FROM LIGHT. STORE IN CARTON UNTIL TIME OF USE.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05